Pharma powerhouse Merck has announced the launch of its novel KRAS G12C inhibitor in patients with advanced lung cancer.

KANDLELIT-007 is a global Phase 3 trial testing the company's investigational oral KRAS G12C inhibitor calderasib (MK-1084) in combination with KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for patients with

KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).

The randomized, open-label, multicenter study (NCT07190248) will compare daily oral calderasib plus subcutaneous KEYTRUDA QLEX to KEYTRUDA QLEX combined with intravenous pemetrexed and chemotherapy (carboplatin or cisplatin) in newly diagnosed patients. KEYTRUDA QLEX will be administered every six weeks in both arms, while chemotherapy follows a standard three-week cycle.

“While outcomes for patients with NSCLC have significantly improved over the last decade, we know there is more work to do. KRAS is the most frequently mutated oncogene in cancer, and the KRAS G12C mutation occurs in approximately 4% to 14% of all patients with lung cancer globally,” said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories.

"By pairing our oral calderasib candidate with subcutaneously administered KEYTRUDA QLEX in this trial, we will evaluate whether this chemotherapy-free combination that requires no intravenous access may help improve outcomes for patients with KRAS G12C-mutant NSCLC.”

The trial aims to enroll approximately 675 patients worldwide. Its primary endpoint is progression-free survival (PFS) in patients whose tumors express PD-L1 (TPS ≥1%). Secondary endpoints include PFS across all participants, overall survival, overall response rate, duration of response, and safety.

Calderasib is also under investigation in multiple other Phase 3 trials: KANDLELIT-012 in KRAS G12C-mutant colorectal cancer, and KANDLELIT-004 in KRAS G12C-mutant NSCLC with high PD-L1 expression.